Latest Drugwonks' Blog
According to the Associated Press, "The Food and Drug Administration announced proposed rules Thursday to reduce potential conflicts of interest among outside experts who advise the government on approval of drugs and other regulated products. The experts would have to disclose any financial ties to the industry under review."
Rather than being treated as experts, AdComm members will now be treated as suspected felons. Not only will they have to fill out a form disclosing the potential conflicts -- but now they must also explain why they should still be able to advise the agency.
What's next? Fingerprinting?
Rather than being treated as experts, AdComm members will now be treated as suspected felons. Not only will they have to fill out a form disclosing the potential conflicts -- but now they must also explain why they should still be able to advise the agency.
What's next? Fingerprinting?
Jonathan Cohn, in an otherwise excellent and thoughtful piece in The New Republicv on how to shift health care systems to a value based reimbursement approach (from a single payer perspective) , resorts to the shibboleth that drug companies are not very innovative as if this is somehow their fault and by design. He relies on the totally useless work of Marcia Angell and Merrill Goozner, neither of whom know much about drug discovery and development and what they do write is selective and misleading.
First, if drug development and discovery were so easy it wouldn't be so expensive. Success rates have fallen not be design. Would any one want to invest $800 billion in a drug only to have it fail. But it happens all the the time. Incrementalism by the way is the norm of science and all things whereas the ability to use one medicine or insight to transform or extend life is rare indeed. Yet Cohn falls into the trap all amateurs fall into and believes that if drug or biotech companies tried a little harder they could nail it. That's arm chair quarterbacking at it's worst. If you think it's so easy to hit a Jaba Chamberlain splitter, why don't you try out for the Bosox and hit it not once every 1000 times but one out of three times. Hit .300 and you are in the Hall of Fame. My brother has worked for a drug company for 20 years and has 3 of the drugs he has worked on approved. That's a lot.
Now as to the heavy lifting. This notion that NIH discovers everything is just not true. The amount of collaboration is astounding and is what separates the US from other parts of the world. Angell and Goozner lie outright to avoid describing the partnerships that shape innovation in America and depict a Golden Age that never existed. Angell asserts that every breakthrough drug started without drug company involvement. She claims that Gleevec, the first cancer drug to target cancerous cells without side effects, was developed without any real input from Novartis, the company that makes the product. Angell says that Brian Druker, a cancer researcher at Oregon Health and Science University, said that Novartis showed little interest in the cancer compound until he discovered its tremendous properties. The real story--from the Journal of the National Cancer Institute--reflects the risky and collaborative nature of drug development, which requires massive capital and biopharmaceutical know-how to turn discoveries into effective treatments. An academic researcher and private company, working together, launched a revolution in the treatment of cancer. You wouldn't know it by reading Angell.
Goozner makes the same claim about drugs developed by Amgen. Everyone involved knows better.
Similarly both Goozner and Angell disdain the revolution in personalized medicine thereby ignoring genomic based science, something that Senator Obama has taken leadership on in the Senate along with Senator Richard Burr.
For instance, The Truth About the Drug Companies also claims there is no real evidence that any one drug is better than another or that most medicines really do much at all. And Angell goes as far as to say: "the idea that patients respond differently to me-too drugs is merely an untested and self-serving hypothesis." Rather, she says, "one or two drugs will do" for most medical conditions. And Goozner still can't figure out the difference between a surrogate end point like blood pressure and a genetic marker which both predicts and controls disease progression.
Cohn's article in the New Republic tries to argue that value based reimbursement can let people have the best of both worlds in a single payer system. I disagree. But he gets the point that health care is an investment and that innovation is valuable. I would recommend that he go beyond Goozner and Angell to understand the role the private sector plays in promoting innovation and just how difficult real invention is.
http://www.tnr.com/politics/story.html?id=53e206dd-c286-43b1-9c5b-079e81ab3474
First, if drug development and discovery were so easy it wouldn't be so expensive. Success rates have fallen not be design. Would any one want to invest $800 billion in a drug only to have it fail. But it happens all the the time. Incrementalism by the way is the norm of science and all things whereas the ability to use one medicine or insight to transform or extend life is rare indeed. Yet Cohn falls into the trap all amateurs fall into and believes that if drug or biotech companies tried a little harder they could nail it. That's arm chair quarterbacking at it's worst. If you think it's so easy to hit a Jaba Chamberlain splitter, why don't you try out for the Bosox and hit it not once every 1000 times but one out of three times. Hit .300 and you are in the Hall of Fame. My brother has worked for a drug company for 20 years and has 3 of the drugs he has worked on approved. That's a lot.
Now as to the heavy lifting. This notion that NIH discovers everything is just not true. The amount of collaboration is astounding and is what separates the US from other parts of the world. Angell and Goozner lie outright to avoid describing the partnerships that shape innovation in America and depict a Golden Age that never existed. Angell asserts that every breakthrough drug started without drug company involvement. She claims that Gleevec, the first cancer drug to target cancerous cells without side effects, was developed without any real input from Novartis, the company that makes the product. Angell says that Brian Druker, a cancer researcher at Oregon Health and Science University, said that Novartis showed little interest in the cancer compound until he discovered its tremendous properties. The real story--from the Journal of the National Cancer Institute--reflects the risky and collaborative nature of drug development, which requires massive capital and biopharmaceutical know-how to turn discoveries into effective treatments. An academic researcher and private company, working together, launched a revolution in the treatment of cancer. You wouldn't know it by reading Angell.
Goozner makes the same claim about drugs developed by Amgen. Everyone involved knows better.
Similarly both Goozner and Angell disdain the revolution in personalized medicine thereby ignoring genomic based science, something that Senator Obama has taken leadership on in the Senate along with Senator Richard Burr.
For instance, The Truth About the Drug Companies also claims there is no real evidence that any one drug is better than another or that most medicines really do much at all. And Angell goes as far as to say: "the idea that patients respond differently to me-too drugs is merely an untested and self-serving hypothesis." Rather, she says, "one or two drugs will do" for most medical conditions. And Goozner still can't figure out the difference between a surrogate end point like blood pressure and a genetic marker which both predicts and controls disease progression.
Cohn's article in the New Republic tries to argue that value based reimbursement can let people have the best of both worlds in a single payer system. I disagree. But he gets the point that health care is an investment and that innovation is valuable. I would recommend that he go beyond Goozner and Angell to understand the role the private sector plays in promoting innovation and just how difficult real invention is.
http://www.tnr.com/politics/story.html?id=53e206dd-c286-43b1-9c5b-079e81ab3474
The recent session of the WHO’s Intergovernmental Governmental Working Group (IGWG) ended without consensus. And that’s a good thing considering that many of the issues on the table would have resulted in a screeching halt to medical progress.
The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is, well, questionable.
Consider this statement from our comrades over at Médecins Sans Frontières:
“Patents are not a relevant factor in stimulating R&D and bringing new products to the market.â€
Really? What about HIV/AIDS, one of the WHO’s “neglected diseases,†where all of antiretrovirals currently in existence were developed under patent protection.
If their grasp on the truth is questionable, their chutzpah is unlimited.
Consider a recent editorial the latest publication of The Lancet where officials of the Thai military junta attack comments offered by patient organizations and other groups to the open forum of the IGWG.
“The issue that attracted the most responses was intellectual property (IP), which was cited in 43 of 68 submissions. Although we were not surprised to see that 11 of 12 organisations directly affiliated with the pharmaceutical industry supported strong IP protection, it was surprising that 14 patient advocacy groups took a similar position, which in several cases was the only point raised in their submissions; three professional associations also took similar positions … We declare that we have no conflict of interest."
This last comment is made after they state that, "We strongly suggest that contributors to public hearings must disclose any conflicts of interest, as required of authors submitting papers to peer-reviewed journals."
The authors did not declare that the Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO) -- and that the GPO stands to significantly benefit financially from a proposed IGWG agenda strongly supports compulsory licensing.
Well, what’s good for the goose is good for the gander. Transparency should cut both ways – even in Geneva.
The IGWG discussions were completely void of innovators -- with pharmaceutical researchers relegated to the sidelines. In their place were activists who are unwilling (and seemingly unable) to engage in any discussion that does not begin and end with removing systems of intellectual property (IP) protection for medicines.
As with many of their ilk, these activists believe in freedom of speech – as long as what you say supports their position. Otherwise you’re a capitalist tool. Their grasp on the truth is, well, questionable.
Consider this statement from our comrades over at Médecins Sans Frontières:
“Patents are not a relevant factor in stimulating R&D and bringing new products to the market.â€
Really? What about HIV/AIDS, one of the WHO’s “neglected diseases,†where all of antiretrovirals currently in existence were developed under patent protection.
If their grasp on the truth is questionable, their chutzpah is unlimited.
Consider a recent editorial the latest publication of The Lancet where officials of the Thai military junta attack comments offered by patient organizations and other groups to the open forum of the IGWG.
“The issue that attracted the most responses was intellectual property (IP), which was cited in 43 of 68 submissions. Although we were not surprised to see that 11 of 12 organisations directly affiliated with the pharmaceutical industry supported strong IP protection, it was surprising that 14 patient advocacy groups took a similar position, which in several cases was the only point raised in their submissions; three professional associations also took similar positions … We declare that we have no conflict of interest."
This last comment is made after they state that, "We strongly suggest that contributors to public hearings must disclose any conflicts of interest, as required of authors submitting papers to peer-reviewed journals."
The authors did not declare that the Thai Ministry of Health owns the Government Pharmaceutical Organization (GPO) -- and that the GPO stands to significantly benefit financially from a proposed IGWG agenda strongly supports compulsory licensing.
Well, what’s good for the goose is good for the gander. Transparency should cut both ways – even in Geneva.
Ed Silverman, the brains behind pharmalot ( www.pharmalot.com) has written a great piece on the trend towards patient reported outcomes in clinical trials. Must reading on this subject for anyone interested in personalized medicine and understanding how and why FDA yanked the QOL indications from Amgen's anemia drugs.
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
http://www.the-scientist.com/article/home/53617/
Now it seems that accessing this data can often be a problem for the researchers who want to use this research to find out what works. An editorial in JAMA by Norman Frost of the Univ of Wisc. Medical School writes that application of HIPAA rules has shut down research or scared off otherwise important studies in the name of privacy:
"The sources of these problems include Office for Human Research Protection and the FDA because they appear to threaten institutions with draconian penalties for minor infractions; institutional (university and other) administrators acting out of fear that their institution could be the next to have its entire research operation suspended by 'getting caught' in one of these minor infractions; and credentialing and certifying agencies for supporting these excesses by including them in their criteria for accreditation."
http://www.sciencedaily.com/releases/2007/11/071113165648.htm
Here's USA Today crawling through the mud -- past Janet Woodcock who officially speaks for the FDA -- to talk to David Graham about Avandia:
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
"This is a warning that's not a warning," said Graham, speaking for himself. "The other thing that's missing is a statement that … there are other alternatives available that work as well as Avandia and don't have this cloud hanging over them."
So Graham wants the FDA to engage in comparative effectiveness which is clearly not it's statutory authority and for which there is no evidence anyways that could be slapped on a label. USA Today runs with this statement instead of the scientific one made by Dr. Woodcock based on the evidence.
No wonder patients are confused and afraid.
http://www.usatoday.com/news/health/2007-11-14-diabetes-heart_N.htm?loc=interstitialskip
Forget the black box for now..here's FDA's Janet Woodcock speaking clearly and confidently on what the agency decided and what the new labeling means:
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
"We are keeping Avandia on the market because we have concluded that there is not enough evidence to conclude that the risk for heart attack or cardiac ischemia is higher than for other type-2 diabetes drugs," the FDA's Dr. Janet Woodcock told reporters in a phone briefing.
The studies have been inconclusive and those that appear to show a risk all compare Avandia to a placebo, she said."
Thus the FDA is closer to the European Medicine Agency than Canada. I am keeping a count to see how many news accounts or blogs note that the EMEA kept Avandia on the market without relabeling. Big zero so far.
http://www.reuters.com/article/governmentFilingsNews/idUSN1421392120071114
John Edwards must know something -- like his campaign is dying. Why else would he decide to jump on the bandwagon of Bernie Sanders (the Senator from Ben & Jerry's) and come out in support of the year's worst idea in health care reform -- prizes rather than patents.
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
Here's what Senator Edwards had to say to a group of medical professionals at Dartmouth-Hitchcock Medical Center on the subject of prizes for pharmaceutical innovation:
"It would also create a different dynamic for drug companies and particularly for breakthrough drugs in big areas like Alzheimer’s, cancer, etc. We’d offer a cash prize for the research and development of these drugs, but they don’t get a patent. So we eliminate the monopoly…The idea is you’ve got to give the financial incentive for the companies to do it but on the flip side you get the products to the market quicker, available quickly and at a much lower cost.â€
Okay -- once more with feeling -- this is just not true. As Joe DiMasi (Tufts University) and Henry Grabowski (Duke University) have argued, under a prize program, pharmaceutical innovators would lack the incentive to innovate. To quote DiMasi and Grabowski, “The dynamic benefits created by patents on pharmaceuticals can, and almost surely do, swamp in significance their short-run inefficiencies.â€
For more reasons this is a crackpot idea see our October 22nd blog entry ("Et tu, Bernie") here:
http://drugwonks.com/2007/10/et_tu_bernie.html
Note to Senator Edwards: You should look into how much money is currently being spent by the biopharmaceutical industry on Alzheimer's research and development. (We assume you have already done so on the issue of breast cancer.)
On March 29th, CMPI and Old Dominion University sponsored a conference on evidence-based medicine and its implications for a cost-centric vs. patient-focused health care future.
Speakers included Carolyn Clancy (AHRQ), Gail Wilensky (Project Hope), Scott Gottlieb (AEI), John Bridges (Johns Hopkins), Peter Elkn (Mayo Clinic), among others.
Here is the final report on the event -- and it's really must reading for anyone concerned about the precarious balance between value and quality -- in short, the future of the American health care system.
Here's a link to the final report:
http://cmpi.org/archives/2007/11/improving_health_care_quality.php
Here's an enticing tidbit from the conclusion of the report ...
"We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care."
An important read.
Speakers included Carolyn Clancy (AHRQ), Gail Wilensky (Project Hope), Scott Gottlieb (AEI), John Bridges (Johns Hopkins), Peter Elkn (Mayo Clinic), among others.
Here is the final report on the event -- and it's really must reading for anyone concerned about the precarious balance between value and quality -- in short, the future of the American health care system.
Here's a link to the final report:
http://cmpi.org/archives/2007/11/improving_health_care_quality.php
Here's an enticing tidbit from the conclusion of the report ...
"We're not at the end of this debate. We're not at the beginning of the end of this debate. But we are at the end of the beginning where at least we can all agree that this is not, and must not be exclusively a debate about saving money. It must be about patient care."
An important read.
MRSA slowing spreading to the community. No drugs in the pipeline in large part to Congressman Waxman's jihad against using clinical trial designs that have brought HIV drugs to market to accelerate approval of medicines for MRSA that kill more people than HIV. Waxman's response? Read his sanctimonious speech on infectious disease control which essentially urges everyone to wash their hands.
http://oversight.house.gov/story.asp?ID=1606
Read this article on how Waxman's attack has helped kill investment and scared the FDA into inferior antibiotic drug approval rates.
http://www.morgenthaler.com/.../Ventures/Articles/
http://oversight.house.gov/story.asp?ID=1606
Read this article on how Waxman's attack has helped kill investment and scared the FDA into inferior antibiotic drug approval rates.
http://www.morgenthaler.com/.../Ventures/Articles/
People who rob banks only steal money. And they only steal it once. But when intellectual property is stolen, the rip-off is ongoing -- and the results can be deadly.
Today, one of the biggest rip-offs going threatens to cripple the U.S. pharmaceutical industry, which faces unprecedented losses from the theft of intellectual property via the mass production of copycat drugs. These drugs are manufactured in places like China, the former Soviet Union, the Philippines and other places where the U.S. Food and Drug Administration has no effective oversight authority — and where the safeguards designed to protect public health taken for granted in America are virtually nonexistent.
Amazingly, some lawmakers in Congress don't recognize the extent of the threat, and are pushing legislation that would make it legal to import prescription drugs from abroad.
Such a measure would lead to a deluge of copycats entering the legitimate supply chain, since it would be virtually impossible to track what's real and prevent phony medications from entering the U.S. market.
Senator Bernie Sanders (I, B&J -- Ben and Jerry's) is fond of taunting the opponents of drug importation by asking, "Where are all the dead Canadians?" Unfortunately, the most recent answer to this question is -- Quadra Insland.
Earlier this year in Canada, a woman who purchased Xanax and Ambien from what she thought was an online Canadian pharmacy died after taking her pills. It turns out the drugs were fake — and were filled with aluminum, tin and even arsenic. They had actually been purchased from a Web site in the Czech Republic and produced in Southeast Asia. But because the medication, in all likelihood, came with labeling and packaging that was indistinguishable from the real thing, there was no way for the victim to know her pills were contaminated with dangerous impurities.
Toxicology tests found three well-known drugs in her system: alprazolam -- more commonly recognized as the anti-anxiety drug Xanax; zolpidem -- which most are acquainted with as the brand-name sleeping pill Ambien; and acetaminophen. Zolpidem is not available in Canada, so it's understandable why Bergeron turned to the internet to try to get the drug.
As the prevalence of counterfeit drugs increases, the long-term viability of legitimate pharmaceutical companies is threatened.
Estimates vary, but the cost of developing a new drug ranges from a low of around $800 million to as much as $2 billion. Much of that investment goes to cover the cost of clinical trials to assure the new drugs are safe and to meet the federal government's many regulations.
Copycats, of course, don't have to worry about any of that; they just take the proverbial ball and run with it — straight to the bank. In fact, it's estimated that counterfeit drug sales will account for $75 billion globally by 2010. According to a recent article in U.S. News & World Report, the counterfeit drug trade is already worth some $35 billion annually.
Anyone who doubts the effect such losses have — both in real terms today and in how the American pharmaceutical industry chooses to invest its dollars and its human talent tomorrow — must have slept through Econ 101.
Here's the rest of the story from today's edition of the Florida Sun-Sentinel:
http://www.sun-sentinel.com/news/opinion/sfl-copycat13forumnbnov13,0,2801251.story
Opening the floodgates to imported drugs of unknown origin is a terrifying proposition. It poses a real risk today, and it threatens our health and well-being tomorrow
Today, one of the biggest rip-offs going threatens to cripple the U.S. pharmaceutical industry, which faces unprecedented losses from the theft of intellectual property via the mass production of copycat drugs. These drugs are manufactured in places like China, the former Soviet Union, the Philippines and other places where the U.S. Food and Drug Administration has no effective oversight authority — and where the safeguards designed to protect public health taken for granted in America are virtually nonexistent.
Amazingly, some lawmakers in Congress don't recognize the extent of the threat, and are pushing legislation that would make it legal to import prescription drugs from abroad.
Such a measure would lead to a deluge of copycats entering the legitimate supply chain, since it would be virtually impossible to track what's real and prevent phony medications from entering the U.S. market.
Senator Bernie Sanders (I, B&J -- Ben and Jerry's) is fond of taunting the opponents of drug importation by asking, "Where are all the dead Canadians?" Unfortunately, the most recent answer to this question is -- Quadra Insland.
Earlier this year in Canada, a woman who purchased Xanax and Ambien from what she thought was an online Canadian pharmacy died after taking her pills. It turns out the drugs were fake — and were filled with aluminum, tin and even arsenic. They had actually been purchased from a Web site in the Czech Republic and produced in Southeast Asia. But because the medication, in all likelihood, came with labeling and packaging that was indistinguishable from the real thing, there was no way for the victim to know her pills were contaminated with dangerous impurities.
Toxicology tests found three well-known drugs in her system: alprazolam -- more commonly recognized as the anti-anxiety drug Xanax; zolpidem -- which most are acquainted with as the brand-name sleeping pill Ambien; and acetaminophen. Zolpidem is not available in Canada, so it's understandable why Bergeron turned to the internet to try to get the drug.
As the prevalence of counterfeit drugs increases, the long-term viability of legitimate pharmaceutical companies is threatened.
Estimates vary, but the cost of developing a new drug ranges from a low of around $800 million to as much as $2 billion. Much of that investment goes to cover the cost of clinical trials to assure the new drugs are safe and to meet the federal government's many regulations.
Copycats, of course, don't have to worry about any of that; they just take the proverbial ball and run with it — straight to the bank. In fact, it's estimated that counterfeit drug sales will account for $75 billion globally by 2010. According to a recent article in U.S. News & World Report, the counterfeit drug trade is already worth some $35 billion annually.
Anyone who doubts the effect such losses have — both in real terms today and in how the American pharmaceutical industry chooses to invest its dollars and its human talent tomorrow — must have slept through Econ 101.
Here's the rest of the story from today's edition of the Florida Sun-Sentinel:
http://www.sun-sentinel.com/news/opinion/sfl-copycat13forumnbnov13,0,2801251.story
Opening the floodgates to imported drugs of unknown origin is a terrifying proposition. It poses a real risk today, and it threatens our health and well-being tomorrow
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
